Reference number
ISO 9626:2016
International Standard
ISO 9626:2016
Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
Edition 2
2016-08
Read sample
ISO 9626:2016
60480
Published (Edition 2, 2016)
This publication was last reviewed and confirmed in 2021. Therefore this version remains current.

ISO 9626:2016

ISO 9626:2016
60480
Language
Format
CHF 129
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Abstract

ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.

It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device.

It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).

It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.

General information

  •  : Published
     : 2016-08
    : International Standard to be revised [90.92]
  •  : 2
     : 23
  • ISO/TC 84
    11.040.25 
  • RSS updates

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